Senior Medical Director, Clinical Development (Oncology / Immuno-Oncology)
Reporting to the VP of Clinical Development, the Senior Medical Director, Clinical Development (Oncology/Immuno-Oncology) will be responsible for the development and implementation of small molecule clinical programs in the therapeutic areas of oncology and immunology/inflammation at Nimbus. We are seeking a highly motivated, collaborative, results-oriented individual with the creativity, resourcefulness, and flexibility to excel in a growing company.
In this role you will:
- Develop programmatic clinical strategy and plans; oversee implementation of clinical programs in line with the clinical strategy and ensure patient safety and data integrity
- Drive and/or oversee the design, execution, analysis, interpretation, and reporting of clinical studies, both early and more advanced, in collaboration with R&D team members, in a matrixed and highly collaborative team environment
- Serve as a Medical Monitor for early (clinical pharmacology, including first in human, DDI, proof of mechanism/concept) to mid-stage and registrational clinical studies; may serve as Project Team Leader for clinical stage programs
- Assess trade-offs and build alignment with team members to enable informed programmatic decision-making
- Support development and implementation of program biomarker plans and ensure successful implementation at study site(s)
- Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions; as appropriate, serve as a company representative for regulatory interactions
These Qualifications Will Help This Role Be Successful:
- M.D. degree with a minimum of 8 years of relevant experience in biopharmaceutical industry, including significant small molecule drug development experience
- Educational background in a relevant scientific discipline (e.g., biology, biochemistry, immunology) and advanced degree(s), including as Doctor of Medicine and post-graduate medical and/or scientific training in oncology and specific industry therapeutic experience in oncology and/or immuno-oncology required
- Prior experience as a functional leader (e.g., early clinical development, clinical pharmacology, experimental medicine, clinical development); project team leadership experience desirable
- Broad understanding of biopharmaceutical drug development, including working knowledge of relevant ICH and GCP guidelines and regulations
- Passion and proficiency in developing and nurturing key partnerships and collaborations with external parties, including investigators, KOLs, CROs, and the broader scientific community (including academia, governmental, or nonprofit organizations), as well as internal discovery and preclinical functions
- Record of significant and successful contributions to regulatory submissions, including INDs/CTAs, and regulatory agency interactions
- Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirable
- Aptitude and interest in serving as a subject matter expert and mentor across the organization
- Excellent written and oral communication skills; experience delivering effective presentations to both technical and non-technical audiences
A Snapshot of Nimbus
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.